The company, whose U.S. headquarters are in East Hanover, NJ, is undergoing operational changes. It filed a federal Worker Adjustment and Retraining Notification (WARN) notice with the New Jersey Department of Labor and Workforce Development saying it planned to restructure the geographic footprint of its global development operations department. That will involve halting two line operations, data management and statistical programming.

It is mandatory that companies file a WARN notice 60 days ahead of a planned mass layoff. By July 28, 204 positions at the East Hanover site will be eliminated.

“Last year, Novartis created the global drug development function to strengthen our ability to deliver breakthrough medicines for patients,” Novartis told NJBIZ in a statement. “As part of this integration, we will be consolidating our data operations organization to our global development site in Hyderabad, India, which allows us to improve efficiencies through increased harmonization and standardization. Regrettably, as a result, 250 positions in the United States (204 of which are in New Jersey) are expected to be impacted by this realignment.”

The company has plans, however, to add approximately 40 manufacturing positions at its Morris Plains, NJ facility. In recent years, the company has cut almost 300 jobs in East Hanover, which were also related to global restructuring. This year it laid off 94 staffers from its headquarters, which was part of a planned 760-person nationwide layoff. In 2012, it cut 1,960 jobs in the U.S.

“The United States continues to play a significantly large role in our business, and we remain committed to our research, facilities and headquarters within New Jersey and several other locations in the United States,” the company stated to NJBIZ.

On more positive news, on May 19, Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval for expanded use of Zykadia (ceritinib) to include the first-line treatment of advanced non-small cell lung cancer (NSCLC) in tumors that are anaplastic lymphoma kinase (ALK)-positive.

The thumbs-up was based on results from the ASCEND-4 study, a randomized, open-label global Phase III trial. It demonstrated that patients receiving first-line Zykadia experienced a 45 percent reduction in the risk of disease progression compared to patients receiving standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.

The European Commission (EC) will now review the submission to determine if the drug’s use will be approved for the European Union. The EC generally follows the recommendations of the CHMP. Approvals typically occur within two months. The first-line use of Zykadia is under Priority Review by the U.S. Food and Drug Administration (FDA).

“Novartis is committed to bringing targeted treatment options to more patients living with lung cancer who may benefit from them,” said Bruno Strigini, chief executive officer of Novartis Oncology (NVS), in a statement. “Today, we’ve taken an important step towards fulfilling the commitment with the potential approval of Zykadia as a first-line treatment option for those in the EU diagnosed with ALK-positive advanced NSCLC.”